ANZUPGO Cream Ref.[114507] Active ingredients: Delgocitinib

Non-melanoma skin cancer

Non-melanoma skin cancer (NMSC), predominantly basal cell carcinoma, has been reported in patients treated with topical JAK inhibitors. Periodic skin examination of the application site is recommended for all patients, particularly those with risk factors for skin cancer.

Excipients with known effect

Benzyl alcohol

This medicinal product contains 10 mg benzyl alcohol (E1519) in each gram of cream. Benzyl alcohol may cause allergic reactions or mild local irritation.

Butylhydroxyanisole

Butylhydroxyanisole (E320) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

Cetostearyl alcohol

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

No clinical interaction studies have been performed with topically or systemically administered delgocitinib (see section 5.2 for in vitro interaction studies). Given the limited metabolism of delgocitinib, application to a limited body surface area (hands and wrists), and minimal systemic exposure of topically applied delgocitinib, there is a low potential for interaction with systemic treatments.

Delgocitinib has not been evaluated in combination with other topical medicinal products and co-application on the same skin area is not recommended.

Pregnancy

There are no or a limited amount of data (less than 300 pregnancy outcomes) from the use of delgocitinib in pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of Anzupgo during pregnancy.

Breast-feeding

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to delgocitinib is negligible (see section 5.3).

Anzupgo can be used during breast-feeding.

When Anzupgo is used during breast-feeding, care should be taken to avoid direct contact with the nipple or surrounding area after applying the cream to the hands and/or wrists.

As a precautionary measure, care should be taken to avoid direct skin contact when taking care of an infant immediately after applying Anzupgo to the hands and/or wrists.

Fertility

No human data on the effect of delgocitinib on fertility are available.

Based on findings in female rats, oral administration of delgocitinib resulted in reduced fertility at exposures considered sufficiently in excess of the human exposure (see section 5.3).

Animal studies did not indicate effects with respect to fertility in males.

Anzupgo has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

The most common adverse reactions were application site reactions (1.0%).

Tabulated list of adverse reactions

Table 1 lists the adverse reactions that were observed in clinical studies. The adverse reactions are presented by MedDRA system organ class and frequency, using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000).

Table 1. Adverse reactions:

^* see Description of selected adverse reactions

Description of selected adverse reactions

Application site reactions

In the pool of three vehicle-controlled clinical studies through 16 weeks, 9 application site reactions (including application site pain, application site paraesthesia, application site pruritus, and application site erythema) were reported in 1.0% of patients treated with delgocitinib cream. 8 application site reactions were mild in severity and 1 was moderate. 7 of 9 occurred within the first week of treatment. No application site reactions resulted in treatment interruption, and the median time to resolution was 3 days.

The event rate of application site reactions in the long-term extension study (0.56 events per 100 patient years of observation) was lower than in the 16-week vehicle-controlled clinical studies (4.11 events per 100 patient years of observation).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Not applicable.